Integrating Expert Opinions: Why Your Clinical Trial Needs an EAC
Evaluating clinical trial endpoints can be complex and require a fair bit of expert judgment. Independent endpoint adjudication committees (EACs) provide necessary support to sponsors and contract research organizations (CROs), focusing on the evaluation of specific medical events and outcomes in clinical trials.
These committees are increasingly best practice to provide an independent, expert evaluation of clinical trial events and an unbiased adjudication to determine if an endpoint has been met.
In this webinar, James Riddle, Advarra Vice President of Research Services & Strategic Consulting, and Barbara Schneider, Advarra Executive Director of Biostatistical Services, discuss the role and function of independent EACs, from charter creation through end of study closeout. They also outline the regulatory guidelines governing when EACs are recommended and prepare you to work collaboratively with an independent EAC on your next trial.
- Define the basic Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines governing when EACs should be considered for clinical trials
- Outline key takeaways to prepare your research program for engaging collaboratively with an independent EAC
- Explain the role of the EAC and how their oversight is different than the data monitoring committee (DMC/DSMB) and the institutional review board (IRB)
- Describe the difference between an EAC and the sponsor’s medical monitor
MCSE, CIP, CPIA, CRQM
Vice President, Research Services & Strategic Consulting
Executive Director, Biostatistical Services
Who should watch?
This content applies to research professionals representing sponsors, CROs, and institutions who are involved in the planning, development, and execution of clinical drug and device trials.
Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.
If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.
Certificate of Attendance
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DATE: February 17, 2022
Time: 1 pm ET | 10 am PT
Duration: 1 hour